Search Results for “EC” – Page 105 – media

【EXPERT Q&A】What are the market access requirements for medical devices entering the Ecuadorian market?

Drugdu.com expert’s response: The following are the market access requirements for medical devices entering the Ecuadorian market: Registration requirements: All medical devices must be registered with the National Agency for Regulation, Control, and Health Surveillance of Ecuador (ARCSA). Registration requirements include product technical documents, manufacturing license, quality management system, labels, instructions, and samples. License requirements: All medical devices require a medical device license in Ecuador to be sold in the market. The license application requirements include a registration certificate, manufacturing license, product instructions, and other relevant documents. Customs requirements: All imports of medical devices must comply with Ecuador’s customs regulations, including providing product information, product pricing, and the identity of the importer. Labeling requirements: All medical devices must have information such as the product name, usage, manufacturing date, expiration date, and the name and address of the manufacturer marked on the packaging. Ecuador’s medical device classification rules are based on ...
- Source: drugdu
- 280
- May 31, 2023
While Pfizer, BioNTech agree to cut COVID vaccine supply to Europe, Moderna sets up shop in China

With demand plummeting for COVID-19 vaccinations, the EU has cut a deal with Pfizer and BioNTech to alter their contract, reducing purchases of the companies’ Comirnaty vaccine by roughly 35%, EU sources told Bloomberg. The companies provided little information on the adjusted contract, calling it a “rephrasing of delivery doses annually through 2026,” in a release. “The agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States,” the companies wrote. “The EC [European Commission] will maintain access to future adapted COVID-19 vaccines and the ability to donate doses.” Some member states opted out of the deal, according to a statement from the EU. Meanwhile, the world’s other premier producer of COVID-19 vaccines, Moderna, is looking to advance sales of its mRNA shot in China, as it has established a unit called Moderna Biotech Ltd. in Shanghai, Reuters reports. Moderna CEO Stephane Bancel visited Shanghai last month, according ...
- Source: drugdu
- 137
- May 31, 2023
【EXPERT Q&A】What steps does the initiation of a drug development project go through?

Drugdu.com expert’s response: The initiation of a drug development project is a complex process, often involving multiple stages and steps. Here is a general flow for reference: 1.Research background and objectives: Determine the background and objectives of the research, including the type of drug to be developed, therapeutic area, and target patient population, etc. 2.Demand assessment: Assess the market demand, business prospects, and potential risks of developing the drug. 3.Preliminary research: Carry out preliminary research and development work, such as drug molecule design, synthesis, screening, and preliminary in vitro experiments, etc. 4.Development plan: Develop a detailed plan for drug development based on the results of preliminary research, including subsequent experimental design, animal experiments, clinical trials, etc. 5.Project application: Write the project application and submit it to the relevant departments for approval. 6.Project evaluation: Experts and review committees evaluate the project application, including the feasibility and scientific aspects of the development plan. ...
- Source: drugdu
- 246
- May 30, 2023
European Commission to receive fewer Pfizer-BioNTech vaccine doses under amended contract

Nicole DeFeudis Editor The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.” The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third. Some member states have opted out of the amendment, and “will continue to be bound by current contractual obligations,” the Commission said. The news comes weeks after the World Health Organization ended its three-year global health emergency for Covid-19, while warning that “the virus is ...
- Source: drugdu
- 116
- May 30, 2023
EU regulators recommend yanking authorization for Novartis’ sickle cell med Adakveo after phase 3 miss

After Novartis’ sickle cell disease medicine Adakveo flopped in a phase 3 trial, European regulators promised to take a closer look at its prior approval. Now, the re-examination has come back with a recommendation to revoke authorization. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended snatching back Novartis’ approval after concluding that the med’s benefits did not outweigh the risks. The decision was based on the results of the phase 3 STAND trial, where the drug didn’t outperform placebo. Specifically, Adakveo (crizanlizumab) couldn’t reduce the number of painful crises leading to a healthcare visit. Adakveo-treated patients saw an average of 2.5 painful crises resulting in a healthcare visit over their first year of treatment, while patients in the placebo group had an average of 2.3. Another nail in the coffin was the average number of crises requiring a home healthcare visit or treatment, which ...
- Source: drugdu
- 158
- May 30, 2023
Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients. Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset. The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible ...
- Source: drugdu
- 102
- May 30, 2023
Janssen reports decline in 2022 net prices as out-of-pocket costs grow

Nicole DeFeudis https://endpts.com/ Editor While net prices for Janssen’s commercial drugs have declined for the sixth consecutive year, out-of-pocket costs have continued to rise for some patients, according to the company’s latest US Pricing Transparency Report. The company provided $39 billion last year in the form of rebates, discounts and fees to commercial health insurers, pharmacy benefit managers and other intermediaries, it said in the report — a more than $5 billion increase compared to 2021. A majority of that, or $11.2 billion, went to commercial payers and PBMs, while 16% (or $6.2 billion) went to the 340B program, 13% ($5.1 billion) went to Medicare and 10% ($3.8 billion) to Medicaid. In 2021, Janssen provided $6.4 billion to the 340B program, $4.6 billion to Medicare and $3.4 billion to Medicaid. “Unfortunately, the reality for millions of patients is growing affordability and health equity gaps caused by underinsurance and inadequate insurance ...
- Source: drugdu
- 104
- May 29, 2023
Boston Scientific cancels $230M stent deal after regulators erect barriers to acquisition

Dive Brief Boston Scientific has canceled a planned $230 million acquisition of a majority stake in M.I.Tech, a Korean manufacturer of non-vascular stents. The U.S. Federal Trade Commission (FTC) shared news of the cancelation, claiming that Boston Scientific took the action in response to investigations by its staff and overseas enforcement partners. Boston Scientific, which is reportedly considering a $10 billion takeover of cardiovascular device maker ShockWave, agreed to buy a 64% stake in M.I.Tech in June and originally expected to close the deal in the second half of 2022. Dive Insight M.I.Tech is a publicly traded Korean manufacturer of medical devices for endoscopic and urologic procedures, including a line of non-vascular, self-expanding metal stents that Boston Scientific has distributed in Japan since 2015. At the time of the agreement, Boston Scientific framed the products as complementary to its portfolio, and the deal as a way to help M.I.Tech expand ...
- Source: drugdu
- 83
- May 29, 2023
【EXPERT Q&A】What aspects should be considered when sending samples to clients? How can we create opportunities for sales techniques, generate chances for client visits, and encourage clients to sign contracts promptly?

When sending samples, it is important to select the right customers with potential demand, pay attention to the details of customized samples, ensure the quality, and provide secure packaging. Including a company catalog and sample list can help customers understand your company and products better. Following up after sending the samples and maintaining regular communication with the customer can help improve the order conversion rate.
- Source: drugdu
- 259
- May 28, 2023
customized sample details order conversion rate sample packaging sample quality samples
Celadon secures medicinal cannabis contract

Celadon will sell a minimum of £3m worth of the high-THC product over the next three years Celadon Pharmaceuticals – a company focused on researching cannabis-based medicines – has announced that it has secured a contract for the commercial supply of its pharmaceutical-grade cannabis product with a UK medicinal cannabis company. As part of the agreement, Celadon will sell a minimum of £3m worth of the high-THC product over the next three years. The initial shipment is expected to be made towards the end of 2023, while the contract could be extended for a further two years with the mutual agreement of the parties. The milestone contract follows the company’s Good Manufacturing Practices registration in January and the update to its Home Office licence, also from earlier this year. Directors at Celadon believe that it is one of a limited number of companies globally with the approvals in place to ...
- Source: drugdu
- 116
- May 27, 2023

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